Regulatory Manager

pfizer.hu

Hybrid
Lead strategic regulatory activities
Obtain and maintain marketing authorizations
Support clinical trial applications
The Regulatory Manager will lead strategic regulatory activities for assigned products and markets to obtain and maintain Marketing Authorizations and support Clinical Trial Applications (where applicable) in line with business goals and legal requirements in partnership with above-country operational hubs

Job Summary

  • The Regulatory Manager will lead strategic regulatory activities for assigned products and markets to obtain and maintain Marketing Authorizations and support Clinical Trial Applications (where applicable) in line with business goals and legal requirements in partnership with above-country operational hubs.
  • Deliver Regulatory Strategy and Advise Cross-Functional Teams For assigned product and market responsibilities, develop and deliver optimal regulatory strategies to support local business and R&D goals for licensed and development products.
  • Pfizer is committed to celebrating diversity and inclusion, allowing for us to be as diverse as the patients and communities we serve.

Matching Summary

The Regulatory Manager will lead strategic regulatory activities for assigned products and markets to obtain and maintain Marketing Authorizations and support Clinical Trial Applications (where applicable) in line with business goals and legal requirements in partnership with above-country operational hubs.

Skills & Requirements

Must-have

  • lead strategic regulatory activities
  • obtain and maintain Marketing Authorizations
  • support Clinical Trial Applications
  • national legislation, guidelines and regulatory environment
  • manage New Registration /Marketing Authorization Applications
  • manage MA Renewal Applications
  • respond to NRA queries

Nice-to-have

  • patient centric company
  • breakthrough culture
  • digital transformation strategy
  • trusting, flexible workplace culture
  • diverse and inclusive workforce
  • Disability Confident Employer

Key Requirements

  • Expert knowledge of national legislation
  • Experience with EU MRP/ Decentralised MAAs
  • Experience with Centralized MAAs
  • Experience with MA Variation Applications
  • Experience with MA Renewal Applications
  • Experience with Clinical Trials Support
  • Experience with Third Party Licenses

Work Rights

Not specified

Tailored Resume

Cover Letter